US FDA’s Precision Medicine Efforts Turn Towards Adverse Events
Next PrecisionFDA challenge aims to detect ‘adverse event anomalies’ including manufacturer-specific patterns and drug-drug interactions.
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Commissioner Scott Gottlieb's statement noting the limitations of FAERS comes just four days after he was quoted in an FDA announcement about the launch of a more searchable portal for the adverse event database.
At White House summit on precision medicine, President Obama emphasized the need to break down outmoded regulations, and suggested barriers between drug and device oversight need to be loosened; FDA and NIH announced a number of new competitions and projects.
Formal dispute resolution was key element in four-month turnaround from rejection by US FDA to approval for golodirsen, the second Sarepta DMD drug to clear the agency after appearing to have minimal prospects.